#1 Clinical Trials Search in Europe

Lumasiran

Clinical trials of Lumasiran are studying people with advanced primary hyperoxaluria type 1, a rare condition that causes high oxalate levels in the body. These studies evaluate how well the treatment works and measure changes in plasma oxalate in patients who are on dialysis and those who are not.

Table of Contents

Trial Overview

The available trial data describe one study of Lumasiran in people with advanced primary hyperoxaluria type 1 (PH1).[1] The study was completed and focused on how treatment affected plasma oxalate, which is the amount of oxalate in the liquid part of the blood.[1]

Who Participated

The trial enrolled patients with advanced PH1, a rare condition that causes too much oxalate to build up in the body.[1] The study included 21 participants and separated them into two groups: people who were not on dialysis and people who were on dialysis.[1]

This group split matters because dialysis means a person is already receiving a treatment that helps clean the blood when the kidneys do not work well.[1]

Trial Design and Phase

This was an interventional study, which means researchers gave the study treatment and then measured the effect.[1] It was a Phase 3 trial, which is a later stage of testing that usually looks at how well a treatment works in a patient group and continues to collect important study data.[1]

The study title also identifies Lumasiran as ALN-GO1 and describes it as an investigational drug in this setting.[1]

What Was Measured

The main outcome was the percent change in plasma oxalate from baseline to Month 6 in both study cohorts.[1] Baseline means the starting point before treatment, and Month 6 means six months after the study began.[1]

The brief summary says the study aimed to evaluate the effect of Lumasiran on plasma oxalate in patients who were not on dialysis and in those who were on dialysis.[1] This shows that the trial was designed to see whether treatment changed oxalate levels in both groups.[1]

What the Results Mean for Patients

For patients, this trial was mainly about whether Lumasiran could lower or change blood oxalate levels in advanced PH1.[1] The study did not only look at one kind of patient; it included both dialysis and non-dialysis groups, which helps researchers understand how the trial treatment performs in different stages of kidney disease.[1]

Because the study is completed, the trial question has already been tested in the planned group of patients.[1]

Trial ID Phase Condition studied Status Enrollment
NCT04152200 Phase 3 Primary Hyperoxaluria Type 1 (advanced PH1) Completed 21

FAQ

  • What condition is being studied in Lumasiran clinical trials? The trial data focus on primary hyperoxaluria type 1 (PH1). This is a rare disease that can lead to high oxalate levels in the blood and serious kidney problems.
  • Who can participate in the trial? The study enrolled patients with advanced PH1. It included two groups: people not on dialysis and people on dialysis.
  • What phase is the Lumasiran trial? The trial is a Phase 3 study. Phase 3 trials usually look at how well a treatment works in a larger patient group and continue to collect safety information.
  • What is the main result the trial measures? The main outcome is the percent change in plasma oxalate from the start of the study to Month 6. Plasma oxalate is the amount of oxalate in the liquid part of the blood.
  • Was the study completed? Yes, the trial status is completed. This means the planned study activities were finished.

Ongoing Clinical Trials on Lumasiran

  • Study on Lumasiran for Patients with Advanced Primary Hyperoxaluria Type 1

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Italy The Netherlands

Glossary

  • Primary hyperoxaluria type 1 (PH1): A rare inherited disease that causes the body to make too much oxalate, which can build up and harm the kidneys and other organs.
  • Oxalate: A natural substance that can become harmful when levels are too high, especially in people with PH1.
  • Plasma oxalate: The amount of oxalate found in the liquid part of the blood, called plasma.
  • Dialysis: A treatment that helps remove waste products from the blood when the kidneys are not working well.
  • Advanced disease: A later or more severe stage of a condition.
  • Phase 3: A late stage of clinical testing that usually includes more patients and checks how well a treatment works.
  • Interventional study: A trial in which researchers give a treatment and then measure its effects.
  • Enrollment: The number of people who joined the study.
  • Baseline: The starting point before treatment begins.
  • Month 6: The point six months after the study starts, used to check changes over time.

References